Age-Related Hair Loss in Men and Women

— Special Report —
U.S. Issues Patent for Advanced
Herbal Formula for
Age-Related Hair Loss
in Men and Women
New, All-Natural Herbal Formula Shown to
Aid in Halting Age-Related Hair Loss and
Restoring Hair Growth in Men and Women
By Jim English
Table of Contents
Glossary of Hair Terms………………………………………………………2
Introduction …………………………………………………………………3
Hair as an Ancient Status Symbol …………………………………………3
Hair in Modern Cultures ……………………………………………………3
Hair Loss a Widespread Problem …………………………………………4
Male Pattern Hair Loss………………………………………………………5
Female Pattern Hair Loss …………………………………………………6
Healthy Follicles for Healthy Hair …………………………………………7
Three Stages of Hair Growth ………………………………………………8
Human Aging and Hair Appearance ……………………………………10
Excessive Hair Loss ………………………………………………………10
Medical Options for Hair Loss ……………………………………………10
Blocking Production of DHT ………………………………………………11
Increasing Blood Flow to Hair Roots ……………………………………11
New Option for Healthy Hair ………………………………………………12
Accidental Discovery Leads to Breakthrough …………………………12
Early Success with Human Volunteers …………………………………14
Human Trials with Alopecia Areata ………………………………………14
B401 and Male Pattern Hair Loss ………………………………………15
Human Trials with Alopecia Totalis ………………………………………17
Restoring Hair Growth Cycles ……………………………………………22
B401 Increases Hair Growth Factors ……………………………………22
Patents Approved in U.S. and Taiwan ……………………………………25
Additional Benefits of B401 ………………………………………………26
Summary ……………………………………………………………………26
Availability …………………………………………………………………26
Abstract: Double-Blind Study of B401 for Androgenetic Alopecia ……27
© 2013 by Jim English and Nutrition Review, LLC. The use of information found in this report for commercial
purposes is prohibited without written permission from Jim English and Nutrition Review, LLC.
All rights reserved. No part of this report may be reproduced or transmitted in any form or by any means
without written permission from the publisher, except for the inclusion of brief quotations in a review.
The information in this report has not been approved by the U.S. FDA and is not intended to provide personal
medical advice, which should be obtained from a medical professional.
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Glossary of Hair Terms
Alopecia Areata: Alopecia is defined as loss of hair from the head or body. Generally,
hair loss in patches signifies alopecia areata. Alopecia areata typically presents with sudden hair loss causing patches to appear on the scalp or other areas of the body.
Androgenic Alopecia: Also known as androgenetic alopecia, alopecia androgenetica,
and male pattern baldness, androgenic alopecia is a form of hair loss caused by an underlying susceptibility of hair follicles to androgenic miniaturization. It is the most common
cause of hair loss, affecting up to 70% of men and 40% of women at some point in their
lifetime. Men typically present with hairline recession at the temples and vertex balding
while women normally diffusely thin over the top of their scalps.
Alopecia Totalis: If hair loss is left untreated, or if the condition does not respond to treatment, complete baldness can result in the affected area, a condition which is referred to
as alopecia totalis.
Axillary hair: Axillary hairs develop on men and women during puberty in areas particularly sensitive to the effects of androgenic hormones, such as the armpits and pubic
area.
Baldness: Baldness is the partial or complete lack of hair growth, and part of the wider
topic of "hair thinning." The degree and pattern of baldness varies, but its most common
cause is androgenic alopecia, alopecia androgenetica, or alopecia seborrheica, with the
last term primarily used in Europe.
Vellus hair: Very fine, short hairs (2 mm, or 1/13 inch long) not affected by androgenic
hormones. Vellus hairs develop over most the body during childhood. Because they contain no pigment, vellus hairs are barely noticeable and often referred to as “peach fuzz.”
Hair: A filamentous biomaterial, composed of protein, notably keratin, that grows from
follicles covering most of the human body. Human follicles produce two types of hair: vellus hair and thicker terminal hair.
Lanugo hair: These are the fine hairs that first appear on the developing human fetus.
Lanugo hairs are normally shed before birth and replaced by vellus hairs by 36-40
weeks gestation.
Terminal hair: Also known as androgenic or body hair, terminal hair is thicker, longer,
and darker than vellus hair. As androgenic hormone levels rise during puberty they trigger additional growth of terminal hairs on the arms, legs, face, chest and stomach.
Males develop more terminal hairs than females, who tend to retain more of their fine
vellus hairs in these areas.
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H
Introduction
umans have been coping with hair loss for a very long time. Like most
mammals, our distant ancestors were protected by a thick covering
of body hair that cushioned their skin and helped conserve body heat
on cold nights. Emerging from cool shaded forests to migrate across the hot
African savannah, humans began to shed body hair to improve temperature
regulation. In addition to helping the body efficiently rid itself of excess body
heat through perspiration, bare skin also allowed for increased production of
vitamin D, a life-saving adaptation that allowed early humans to survive as they
trekked north to settle in Europe and Asia. Over time, humans lost most of their
hair, with the notable exception of a thick patch retained on the scalp to shield
the top of the head from the damaging effects of unfiltered ultraviolet radiation
when the sun was directly overhead.
Hair as an Ancient Status Symbol
As humans spread out to colonize the rest of the globe, scalp hair evolved
into complex ornamental structures that were easily shaped to form a variety of styles that, over time, came to be recognized as potent symbols of
status and power (Fig.1). For sparsely spread out humans, hairstyles served
as a vital source of information when encountering other groups of humans.
Even at a great distance, hairstyles conveyed visual cues that could reveal
the ages, gender, health, physical strength, temperament, reproductive status, and most importantly, presence of potential mates among individuals
of a strange tribe. Such clues could help nomadic tribes feel confident in
approaching potential allies, or provide warnings to avoid potentially dangerous enemies.
Hair in Modern Culture
Far from being a simple vestigial holdover from our furry ancestors, hair continues to exert a significant influence on human relationships in the modern
world. In addition to informing others about our age, gender and overall
health, contemporary hairstyles embed visual clues that express our social
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position, economic status, cultural habits and religious beliefs. And just as
our ancestors, we respond to such cues when making important decisions
regarding interactions with others, especially in personal and business relationships. Considering how the amount, type and condition of our hair can
impact the direction and course of many of life’s most important events, it’s
little wonder that modern, longer-lived humans experience significant levels
of anxiety when confronted with thinning hair.
Fig. 1. The Venus of Brassempouy is a 25,000 year-old fragmentary ivory figurine discovered in a cave near Brassempouy, France in 1982. This rare palaeolithic figure is one of
the earliest known realistic representations of a human face and hairstyle.
Hair Loss a Widespread Problem
While losing some hair on a daily basis is normal, shedding more than 100
hairs per day is considered excessive and may indicate a serious problem.
Contrary to popular belief, many people who suffer from excessive hair loss
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are extremely unhappy with their situation and would do anything to change
it. Hair loss affects every aspect of life — interpersonal relationships as well
as professional ones (it is not uncommon for men to change their career paths
because of hair loss).
Fig. 2. Progressive loss of hair as classified on the Hamilton–Norwood chart,
ranging from stages I through VII.
Male Pattern Hair Loss
Male-pattern hair loss (Fig. 2), also known as androgenetic alopecia, is the
most common form of balding, affecting roughly 40 million men in the US.
Approximately 25 percent of men with male-pattern hair loss will begin to lose
their hair by age 30, and up to 66 percent will begin balding by age 60. Malepattern hair loss is closely linked to androgens—sex steroid hormones synthesized from cholesterol in the testes, ovaries and adrenal glands. The
primary androgens—testosterone, pregnenolone, androstenedione and
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DHEA (dehydroepiandrosterone)—normally regulate male and female sexual
development and behavior by binding to receptors on target cells throughout
the body.
Another androgen, dihydrotestosterone (DHT), has been identified by researchers as a primary cause of male pattern baldness. DHT is synthesized
from testosterone by the enzyme 5alpha-reductase. When DHT binds to receptors in the hair follicle, it causes the hair roots to shrink, or "miniaturize.”
DHT has also been shown to shorten the amount of time hair spends in the
growing (anagen) phase from as long as five years to as little as two months.
In 1998, researchers discovered that men genetically prone to male pattern baldness have significantly higher numbers of androgen receptors in the
hair follicles located across the forehead and scalp—exactly those areas
where hair loss first appears in androgenic alopecia. Additional research has
shown that these androgen-sensitive follicles also have significantly higher
levels of 5alpha-reductase (1.5 to 3 times higher) and DHT than hair follicles
from other areas of the scalp.1
Over time, DHT’s miniaturizing effect can shrink large adult hairs, resulting
in finer, vellus hairs only 10% as wide as normal and barely an inch long. This
leads to the “peach fuzz” common to early stage balding. At this stage if the effects of DHT aren’t reversed or halted in time, the hair follicles will shrink down
until they eventually vanish, resulting in complete baldness in the affected area.
Female Pattern Hair Loss
Hair loss isn’t exclusively a male problem—approximately 50% of all women
over the age of 50 experience a similar condition, referred to as female androgenic alopecia (Fig. 3). Symptoms in women are generally less severe
than those experienced by men, appearing as an overall thinning of hairs
across the top of the head, and the gradual loss of hairs down the center partline of the scalp. The reason women experience milder symptoms is due to
hormonal differences—women produce significantly lower amounts of testosterone than men (about 95% less on average). Women also produce lower
levels—about 60 percent less than men—of the enzyme 5α-reductase that
converts testosterone into DHT.
Additionally, women produce higher levels of another enzyme, aromatase
(estrogen synthase), that converts testosterone into the female hormone,
estradiol. While males also produce small amounts of aromatase, research
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Fig. 3. Progression and severity of receding hair line in women with androgenetic hair loss is
generally classified on the Ludwig scale, ranging from stages I through III.
has shown that aromatase levels in the frontal and rear scalp follicles in
women are 4 to 6 times higher than in men, which is why women rarely lose
hair in these areas.
Healthy Follicles for Healthy Hair
Hair follicles are among the most active and fastest growing structures in the
body. Human hairs are produced by follicles—specialized organs that cover
the entire body, with the exception of the palms and soles of the feet. Follicles
are composed of three major structures—the dermal papilla, hair matrix, and
hair shaft. (Fig 4).
The dermal papilla, a pear-shaped structure located at the base of the hair
follicle, is comprised of connective tissues and a capillary loop containing tiny
blood vessels that provide the nutrients required for hair growth.
The papilla is surrounded by the “matrix”—a bulb-shaped collection of
specialized epithelial cells that produce a protein, keratin, that actually forms
the hair fiber. The matrix also contains melanocytes, specialized pigment cells
that infuse the growing hair shaft with melanin, the compound that gives otherwise transparent hair its natural coloring.
Different types of melanin produce different colors—yellow, rust, brown, and
black—that combine to produce a wide variety of hair colors, ranging from blond
to brown to pitch-black. Red hair is the result of another type of coloring agent,
the iron-containing pigment called trichosiderin.
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Fig. 4. Cutaway schematic of a hair follicle showing structure of shaft, bulb and microcirculatory vessels.
Three Stages of Hair Growth
Mature human hair growth occurs in three distinct phases—growth, transition and rest – that are collectively referred to as the hair cycle (Fig. 5).
1. Growth Phase (Anagen): Each hair cycle begins with a growth
(anagen) phase. This is marked by rapid cell division in the hair matrix that
builds up layers of keratin to form a single hair shaft that grows out from
the follicle at a rate of up to one inch per month. This growth phase typically
lasts two to six years. At any given time, about ninety percent of all scalp
hairs are in the active growing phase.
2. Transitional Phase (Catagen): At the end of the anagen phase,
hair growth ceases and the follicle enters the transition (or catagen) phase.
During this phase hair matrix cells begin to die off as the follicle base and
bulb begin to shrink. Over time, this shrinkage (miniaturization) pinches
off the lower hair bulb, cutting off access to the blood vessels and circulaPage 8
tion necessary for hair growth. At any given time, one to two percent of all
hair follicles are in this transition phase, which usually lasts for between
one to two weeks.
3. Resting Phase (Telogen): The final stage of the hair cycle is the
resting (or telogen) phase. During this phase, the mature hairs reside in
the follicle five to six weeks before falling out. Approximately 10 percent of
all hairs are in this transition period at any time, accounting for the normal
shedding of thirty and fifty hairs each day.
Fig. 5. Three stages of human hair growth: Anagen (growth) phase, lasts from two to six
years; Catagen (transitional) phase, lasts from one to two weeks; Telogen (resting) phase,
lasts five to six weeks.
After shedding the hair shaft, the follicle begins a new cycle of hair growth,
marked by the swelling of the dermal papilla and the formation of a new capillary loop. As blood vessels reattach to the papilla, they grow and expand
four-fold to provide the hair matrix with the nutrients necessary for growing
new hair.
The entire process—growth, transition and rest—makes up one complete
hair cycle. Each hair follicle is limited to the number of hair cycles that can be
completed—estimated to between 20 and 25 cycles—before reverting to vellus hairs (peach fuzz) and eventually disappearing.
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Human Aging and Hair Appearance
In humans, the hair growing (anagen) phase is at its longest—ranging up to
7 years—and the transition/resting phases are at their shortest—lasting only
about 4 months—throughout youth and adolescence. As a result of the great
amount of time devoted to supporting hair growth in adolescence, hair is at
its healthiest and most attractive throughout this phase of life.
Beginning at around age 35, changes in hair cycles begin to affect the
density and overall appearance of hair. With each successive cycle, the
amount of time spent in the growing phase is reduced, resulting in shorter,
thinner hairs. Additionally, the amount of time spent in the resting phase
lengthens, extending the period between when a hair falls out and when a
new one grows back. The result of these changes is a gradual reduction in
overall hair density and appearance.
Changes in hair color also begin to appear at this time. As pigment-producing melanocytes gradually die out, hairs begin to lose their luster and
color, slowly turning gray and eventually becoming totally white.
Excessive Hair Loss
While gradual hair loss is a normal part of human aging, for many people excessive hair loss, or balding, is a significant source of anxiety. Based on several
characteristics, hair loss can be roughly divided into two categories—temporary
and permanent. Temporary hair loss, which is usually caused by excessive
stress, poor diet, hormonal imbalance and endocrine dysfunction, can often be
restored within six months to two years after eliminating the underlying cause(s).
Permanent hair loss is caused by genetics and is considered irreversible.
Medical Options for Hair Loss
An ideal solution for hair loss would be one that 1) promotes new hair growth
while extending the anagen (growing) phase, 2) lengthens the catagen (transitional) phase, and 3) shortens the telogen (resting) phase.
The two most widely-used medical treatments for androgenic alopecia—
Propecia® and Rogaine®—offer partial solutions by addressing hair loss in
two completely different ways. Propecia primarily works to halt hair loss by
blocking the production of the follicle-damaging hormone, DHT, while Rogaine
aims to support hair growth by increasing blood flow to the hair roots.
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Option 1: Blocking Production of DHT
Propecia (Finasteride), is an oral prescription drug from Merck & Co. that was
first marketed as Proscar® for the treatment of enlarged prostate (benign prostatic hyperplasia or BPH). Overabundance of DHT has been established as
a contributing factor in the development of BPH and prostate cancer. Proscar
(5 mg finasteride) has been shown to effectively lower DHT levels by preventing the enzyme, 5alpha-reductase, from converting testosterone into
DHT. Soon after Proscar was approved, Merck researchers noted that men
taking finasteride were showing signs of hair regrowth. This led Merck to
begin testing a lower dose of the drug finasteride as a potential treatment for
hair loss, and in 1997 the FDA approved Propecia™ (finasteride 1 mg) for
the treatment of androgenic alopecia in men.
Following its introduction, Propecia was shown to be highly effective at decreasing DHT concentrations in the blood (by up to 70%), and the scalp (by up
to 60%) to reverse DHT-related hair loss of the vertex (at top of head) and anterior mid-scalp area. Unfortunately, there were some serious side effects.
In addition to being present in hair follicles, 5α-reductase is also abundant
in the prostate and seminal vesicles, where it plays a vital role in the healthy
development and maintenance of normal physiological functions. Reduction
of DHT in these organs has now been linked to unwanted side effects in men,
including decreased libido, sexual dysfunction, and a reduction of mature
sperm count. Additionally, women cannot use Propecia, and Merck explicitly
warns women who are or may be pregnant not to even handle crushed or
broken Propecia tablets, since the active ingredient may cause abnormalities
of a male baby’s sex organs.
Option 2: Increasing Blood Flow to Hair Roots
Minoxidil (Rogaine) was originally developed as an oral drug for the treatment
of hypertension, based on its ability to relax vascular smooth muscles and
produce peripheral vasodilation. By directly stimulating circulation to the hair
follicles, Minoxidil was found to extend hair and redirect resting hair follicles
into new growth.
Animal experiments have shown that Minoxidil works, in part, by increasing vascular endothelial growth factor (VEGF) to promote hair growth and reactivate dormant hair follicles. However, when taken orally to restore hair,
minoxidal was also found to have a number of side effects, including unPage 11
wanted hair growth in women (hirsutism). Most of these side effects were
averted by the introduction of a topical form of Rogaine for use as an external-use hair-restorer in 1988.
Clinical literature shows that Minoxidil performs excellently in preventing
hair loss (80%), but less than 20% of patients with androgenetic alopecia experience actual hair growth. Clinical observations indicate that the effects of
Minoxidil can be seen within 6-12 months of continual use. Yet once treatment
has stopped, within three months all hair growth effects disappear and revert
back to the untreated state.
New Option for Healthy Hair
In Traditional Chinese Medicine (TCM), conditions such as hair loss are addressed by balancing both the “surface” and “root” levels of the problem. Now,
after 10 years of intensive research, development, and clinical evaluation, a
patented, all-natural herbal TCM supplement is available in the United States
to aid in halting age-related hair loss while promoting healthy hair growth.* By
promoting healthy circulation in the tiniest blood vessels (microcapillaries) that
supply nutrients and oxygen to the hair follicles, the formula supports thicker,
healthier hair, improved skin tone and overall health and vitality.*
Accidental Discovery Leads to Breakthrough
Serendipity, defined as the accidental discovery of something unexpected,
played a key role in the development of the new herbal hair restoration formula, B401. In 2002, a leading medical lab in Taiwan had recruited a team of
herbal researchers and veterinarians to work on developing a new, natural
treatment for a common inflammatory skin disease that cause painful skin
blisters and hair loss in household pets.
After two years of R&D, the team developed an all-natural herbal formula
that was just as effective as the antibiotics and steroids commonly used to treat
afflicted animals, but with the added benefit of being free of the dangerous side
effects that typically limit the use of such drugs in pets (Fig. 6).
As the lab director reviewed the research team’s final report, his attention
was drawn to a section that detailed a surprising observation. In addition to
regrowing all of their lost hair at a surprisingly rapid rate, all of the treated animals were maintaining thicker, healthier fur coats, even during warm periods
when seasonal shedding of hair was expected.
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Fig. 6. Results after 4 weeks of treatment with experimental herbal hair support formula,
B401, resulting in a gradual return to normal hair growth.
Fig. 7. Serious loss of hair due to Alopecia X on the left, and following two months of treatment with B401 on the right, with a gradual return to normal hair growth.
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Intrigued by this unexpected finding, the researchers decided to test the
formula on a group of dogs suffering from Alopecia X. Also referred to as
Black Skin disease, Alopecia X causes hair loss on both sides of a dog’s body
and is generally considered an untreatable disorder. After a few months of
treatment with B401, the animals had completely recovered from the condition and regrown all of their previously lost hair (Fig. 7).
Early Success with Human Volunteers
Inspired by the formula’s ability to halt hair loss and restore hair growth in animals, the researchers decided to see how the formula worked in humans. The
results of a small trial with five volunteers experiencing abnormal hair loss were
promising, and the lab approved a full-scale program designed to optimize and
refine the formula for long-term human use.
Human Trials with Alopecia Areata
The earliest trials involved a group of patients diagnosed with Alopecia areata,
or “spot areata.” In early stages, Alopecia areata causes clumps of hair to fall
out with a gentle pull, leaving patients with one or more bare spots on the scalp.
Alopecia areata occurs in young people at a rate of approximately 17 per
100,000 per year, and while the condition isn’t harmful, the psychological impact is problematic for young patients. Fortunately, the condition is generally
temporary, and 80% of the patients eventually self-heal.
In addition to the form seen in younger people, a more pervasive form of
Alopecia areata appears in women (and occasionally men) over the age of
35. Also characterized by extensive hair loss, the condition usually clears up
within one to two years, but the psychological stress of going bald makes this
condition a profitable area for treatments at hair loss centers.
The most common treatment for Alopecia areata involves monthly injections of corticosteroids, and twice-a-day external application of 5% minoxidil.
Treatment generally requires 8-12 weeks before hair begins to regrow.
AA Case 1: Mr. W. was a 50-year-old sales manager who had lost a large
amount of hair in the occipital region. He came to the research center after
being treated with steroid medications for one month. The steroids had not
alleviated his alopecia areata, and the area of hair loss was continuing to
spread. After one month of taking B401, Mr. W. reported significant improvement in his condition, and within two months all of his hair was restored.
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AA Case 2: C. was a 15-year-old student with several bald spots across
the back of her head. By the time C. came to the center, she had already
completed a month of conventional drug treatment without any improvement and was emotionally stressed from additional hair loss. After taking
B401 for one month, her hair loss stopped and new hair started to grow
back. Within several months all of her hair was restored.
AA Case 3: A family brought in a 10-year-old student who had begun to
lose her hair. Her family had her treated by both Chinese and Western
doctors, but there was no improvement and her hair loss was increasing.
After 50 days of treatment with B401, her condition had improved significantly, with older bald spots filling in, and hair loss at newer spots significantly slowed.
B401 and Male Pattern Hair Loss
Pleased with the results of the Alopecia areata trial, the lab next began testing
B401 on subjects with male pattern baldness. The results revealed that almost all men with stage 3 or 4 hair loss reacted exceptionally to B401 within
six months, regrowing fine hairs on the top of the scalp that grew thicker and
longer over time. Subjects with stage 4 to 5 hair loss were more likely to experience significant regrowth; however, improvements in stage 7 male-pattern
baldness were only noticeable close up, with thinner hairs becoming thicker
and longer, but with little change on the forehead.
The following images (Figures 8 through 11) document the results of four
cases of male pattern baldness after treatment with B401.
Fig. 8. C., 43-years-old, after taking B401 for 1.5 years, revealing reduced hair loss, thicker,
denser hair, and increased coverage across middle of scalp.
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Fig. 9. Mr. L., 29-years-old, after taking B401 for one year, revealing increased hair density
and overall hair coverage.
Fig. 10. Mr. S., 38-years-old, after taking B401 for one month, revealing thicker hairs and
increased hair density.
Fig. 11. Mr. D., 40-years-old, after taking B401 for eight months, revealing reduced hai
and loss, regrowth of original hair across top of scalp.
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Human Trials with Alopecia Totalis
Following the positive outcome of the male pattern baldness trials, the researchers began to test the new formula on several women diagnosed with
Alopecia totalis, a condition that causes lymphocytes to attack hair follicles during the growth phase of the hair cycle. In extreme cases, Alopecia totalis can
result in the total loss of hair on the head, face, eyebrows and eyelashes within
six months. Full recovery is rare, and even with effective treatment, new hair
growth in patients with alopecia totalis is often incomplete.
Fig. 12. Ms. Y., 26-years-old, diagnosed July 21, 2006, arrived at the clinic after
being told her condition was incurable.
AT Case 1: Ms. Y., 26-years-old, was diagnosed with Alopecia totalis in July,
2006. Early signs of hair loss were attributed to stress from work and school,
but within two months all of the hair on her head, eyebrows included, had
dropped out. Conventional treatment at two Western hospitals failed to address
the problem, and by the time Ms. Y. entered the B401 trial all that remained of
her hair were a few black strands in the occipital region (Fig. 12).
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Fig. 13. Ms. Y., 26-years-old, after taking B401 for six months.
Fig. 14. Ms. Y., 26-years-old, after taking B401 for 18 months.
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After taking B401 for six months, new hair began to appear (Fig. 13). After
two years of treatment, Ms. Y. fully regrew her hair. (Fig. 14) Two years after
the completion of her initial treatment, Ms. Y. reports that her hair is still full
and strong, with good volume and no further loss.
AT Case 2: Ms. L. had previously tried every other available treatment to reverse her hair loss, but all failed. She had been completely bald for eight
years by the time she enrolled in the trial. After taking the formula for six
months, there was no improvement in her condition and Ms. L. decided to
discontinue treatment.
Fig. 15. Ms. H., 28-years-old, before taking B401.
AT Case 3: Ms. H., 28-years-old, experienced serious, unexplained hair loss
in the summer of 2007, and within two months had lost all of her hair, including
eyebrows (Fig. 15). Ms. H. began to experience new hair growth within one
month of taking B401 (Fig. 16). Significantly, Ms. H. reported that her previPage 19
ously white hair was growing back in her natural color, black (Fig. 17). The
researchers expected that newly grown hair would not regain its original color
for at least 2 or 3 full hair cycles, so her case was especially interesting. Ms.
H. reached a near-full recovery in six months (Fig. 18).
Fig. 16. Ms. H., 28-years-old, after taking B401 for 2 months, revealng thickening, longer
hairs in occipital region.
Fig. 17. Ms. H., 28-years-old, after taking B401 for 2 months.
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Fig. 18. Ms. H., 28-years-old, after taking B401 for 6 months.
Unfortunately, Ms. H. stopped taking B401 after her initial treatment and experienced a relapse after six months.
Note: Each of these three cases had completely different results: the first
successful, the second ineffective, and the third a relapse. Note that in the
second case, researchers had previously predicted that newly grown hair
would not regain its original color for at least 2 or 3 full hair cycles, so her
case was especially interesting. From these three cases, the scientists concluded that the longer one waits before beginning treatment with B401, the
greater the chances for permanent and unrecoverable damage to hair follicles. The scientists also concluded that early treatment at the first signs of
hair loss improves the probability of total recovery. Additionally, treatments
have to be continued until the underlying condition is eliminated to prevent
a future recurrence of hair loss.
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Restoring Hair Growth Cycles
Modifying hair follicle growth cycles is a complicated and delicate matter. Current scientific research has managed to identify only a handful of the numerous growth factors and hormones believed to be involved in hair proliferation
and growth. For example, Fibroblast Growth Factor 3 (FGF-3) and Fibroblast
Growth Factor 5 (FGF-5) are both known to contribute to shifting follicles from
hair growth to follicle degradation. Conversely, Insulin-like Growth Factor
(IGF-1) and Fibroblast Growth Factor 7 (FGF-7) have been shown to support
hair growth by lengthening the telogen (growth) phase of hair follicles. Additionally, Vascular Endothelial Growth Factor (VEGF), Hepatocyte Growth Factor (HGF) and Endothelial Cell Growth Factor (EGF) have also been shown
to aid in extending hair growth period.
Currently these growth factors and hormones are useful for filtering hair
growth regulators and interpreting their mechanism of action. However, given
the gap between the basic research (in vitro) and clinical applications (oral),
most current treatments are limited to topical hair growth products. Saw palmetto extract, for example, can inhibit 5α-reductase in vivo, but has no effect
when taken orally, which is why it is commonly used in topical hair products.
Adenosine, which has been shown to enhance FGF-7 levels in hair follicles,
is another popular ingredient for topical hair tonics. Last but not least, numerous plant extracts are added to hair creams to block the effects of FGF-5.
Nevertheless, these topical treatments are all restricted to addressing the
“surface” issues involved in hair loss, instead of the “root” causes.
B401 Increases Hair Growth Factors
According to animal studies commissioned by the Agriculture Department of
Taiwan and completed by the Institute of Animal Science, the patented formula,
B401, was found to enhance levels of Vascular Endothelial Growth Factor
(Fig. 19) and Hepatocyte Growth Factor (Fig. 20) in hair follicles. B401 was
also shown to increase the number of active hair follicles (Fig. 21), while
promoting faster growth and increased length of individual hairs (Fig. 22).
Coupled with the inclusion of botanical ingredients known to effectively
enhance skin blood circulation, these findings suggest that B401’s mechanism of action is superior to that of currently available treatments. Human
case studies indicate that B401 can prevent hair loss in 85% of subjects within
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Fig. 19. Increase in local hair follicle expression of Vascular Endothelial Growth Factor following administration of B401 for 28 days.
Fig. 20. Increase in Hepatocyte Growth Factor concentration following administration
of B401 for 28 days.
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Fig. 21. Increase in the number of active hair follicles following administration of B401
for 28 days.
Fig. 22. Increase in hair growth following administration of B401 for 15 days.
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six weeks while promoting hair growth, improving skin texture, and boosting
energy levels. Each of these effects were listed in the patent applications that
were subsequently approved in both Taiwan and the United States. And because B401 is comprised of essence herbs traditionally used to support
healthy endocrine and hormone levels, the formula may also aid in supporting
healthy cardiac function.
Numerous clinical cases have shown the Taiwan-US patent formula B401,
if used uninterruptedly with sufficient amount, can stop abnormal hair loss
within four to eight weeks. New hair generally begins to appear on the scalp
in three to six months time. Additionally, original hair color is likely to emerge
amongst white hairs six months later.
Patents Approved in U.S. and Taiwan
After years of study, B401 was successfully released as a new food-based
formulation for reducing shedding. In 2010, patents for B401 were approved
in both the United States (Patent Number: U.S. 7,838,048 subject: Medical
herb composition for inhibiting shedding of a mammal's hair and method for
preparing the same) and Taiwan (Taiwan patent number I 329 491. Title: Chinese medicine composition for hair loss reduction and its preparation
Fig. 23. Taiwan and the United States Patents.
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method). According to the Intellectual Property Office of Taiwan, B401 is the
only anti-hair loss patent ever granted in Taiwan.
Additional Benefits of B401
In addition to halting hair loss and increasing hair growth, the proprietary
blend of nourishing herbs in B401 have also been shown to support and benefit general health. Case studies have shown that those taking B401 report
experiencing increased levels of vitality and energy after 1 to 2 weeks, and
improved skin tone and texture after 6 to 8 weeks.
Animal tests have also shown that the formula exerts anti-fatigue and liverprotective functions, and in vitro trials have identified significant antioxidant
effects. Animal studies have also revealed significant anti-aging benefits.
Summary
Age-related hair loss is caused by two major factors: hereditary-pattern baldness and microcirculatory dysfunction from the lack of nutrition to the hair follicles. The current medical solutions are Minoxidil (Rogaine) and Finasteride
(Propecia). Yet each has serious side effects. In recent years, there have
been studies that indicate certain food material herbs can alleviate shedding;
however, the treatments rendered are limited to external use.
After 10 years of intensive research, development, and clinical evaluation,
B401 herbal hair support formula for men and women is now available in the
United States. B401 addresses hair health from the inside out by combining
essence herbs traditionally used to reduce excessive hair loss with a unique
blend of botanicals shown to help support circulation to nourish the skin and
follicles.* The result is a unique, patented, all-natural herbal supplement for
addressing age-related hair loss, promoting healthy hair growth and improving skin tone, energy and vitality.*
Availability
B401 is currently distributed under license in several countries. In Taiwan
B401 is available as Beau Top, and in the U.S. as PriaPlex®.
* These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.
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Results of Double-Blind Study of
B401 for Androgenetic Alopecia
Researchers recently completed a six-month, randomized, double-blind
placebo-controlled study designed to evaluate the efficacy of B401 for male
pattern baldness (Androgenetic Alopecia, or AA). Researchers enrolled 40
patients (31 male, 9 female) diagnosed with male pattern baldness. At the
end of six months, 32 patients had completed the full trial, and 8 had dropped
out due to non-compliance issues (5 in the placebo group and 3 in the treatment group).
Fig. 1. Results of six month’s use of B401, showing thicker hair growth in subject with stage III male pattern
baldness (top) and new fine hairs in subject with stage IV male pattern baldness (bottom).
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The study found that 9 of the 17 treatment subjects taking B401 (52.9%) experienced significant hair growth, as measured by dermatoscopy and clinical
photographs independently scored by dermatologists blind to the treatment
conditions (Fig. 1). By comparison, only 2 of the 15 subjects (13%) receiving
the placebo showed any signs of hair growth.
The primary goal of this short, six-month study was to determine the efficacy of the formula in the intention-to-treat population — i.e., men and
women with androgenetic alopecia. The significance of these results, after
only six-months of treatment, become especially apparent when compared
to similar measurements after treatment with Finasteride (brand names
Proscar and Propecia) for 1 year (44%), 2 years (61%) and 5 years (48%) of
use (Fig. 2).
Fig. 2. B401 results after six months, as compared with long-term (5-year) multinational experience with
finasteride 1 mg in the treatment of men with androgenetic alopecia.
1. Long-term (5-year) multinational experience with finasteride, 1 mg, in the treatment of men with
androgenetic alopecia. European Journal of Dermatology. Volume 12, Number 1, 38-49, 2002
2. B401, 6 months Double Blind Placebo Controlled Clinical Study, Chung Shan Medical
University Hospital, Dermatology Department, 2012.
One of the most interesting outcomes of the study was that each of the subjects receiving B401 reported that their existing abnormal hair loss had halted
during the trial. In other words, B401 completely stopped all age-related hair
loss in 100% of the cases.
Summary
By age 35, two-thirds of American men will have some degree of appreciable
hair loss and by age 50 approximately 85% of men have significantly thinning
hair. About 25% of men who suffer from male pattern baldness begin the
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painful process before they reach 21. Contrary to societal belief, most men
who suffer from male pattern baldness are extremely unhappy with their situation and would do anything to change it. And hair loss isn’t an exclusively
male issue — approximately 50% of all women over the age of 50 experience
a similar condition referred to as female androgenetic alopecia.
In this short six-month trial, 100% of both male and female subjects taking B401 for androgenetic alopecia experienced a total cessation of abnormal
hair loss, and 53% experienced significant new hair growth. In addition to
stopping the progression of age-related hair loss, B401 was shown to support
restoration of healthier, thicker hair in existing follicles.
Additional studies are underway to determine a fuller clinical picture of
longer periods of continuous use of B401.
Clinical Protocols
Patients between 20 to 45-years-old of both sexes with androgenetic alopecia were enrolled in the clinical trial. Exclusion criteria included hormone
imbalances, metabolic diseases, cancers, unknown etiology of alopecia,
infection, irritation or pain in the scalp. The pilot study, lasting 6 months,
was a randomized, double-blind, placebo-controlled study involving 40 patients. 20 patients in the treatment group received 6 caplets of B401 daily
(3 grams), and 20 patients received a placebo. Male patients were diagnosed with alopecia based on the Norwood-Hamilton scale, and female patients were diagnosed with alopecia based on the Ludwig scale.
Dermatoscopy and clinical macrophotographs were recorded monthly and
independently scored by three dermatologists blind to treatment condition.
Each patient was monitored with full lab clinical tests to measure TSH,
DHEAs, testosterone, estrogen, kidney and liver function tests, and complete blood count. Clinical endpoints include Norwood-Hamilton and Ludwig
scale, Fatigue Symptom Inventory, self-reporting hair loss, and color of hair.
Adverse events were also monitored (none reported). Chi-square test was
0.01 <p <0.025 which showed statistical significant difference between the
treatment and placebo group. Statistical data analysis includes use of student t-test and Wilcoxon rank-sum test, along with the Kolmogorov–
Smirnov test (K–S test) for the testing for normality of the distribution.
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